Logo

Arcutis Reports the Health Canada Acceptance of New Drug Submission for Review of Roflumilast to Treat Plaque Psoriasis

Share this

Arcutis Reports the Health Canada Acceptance of New Drug Submission for Review of Roflumilast to Treat Plaque Psoriasis

Shots:

  • The NDS submission was based on the P-III program & two P-III (DERMIS-1 & 2) OLE studies to evaluate roflumilast (0.3%) vs vehicle in patients with PsO. The US FDA’s action date is April 2023
  • Both the trial met their 1EPs & showed an IGA success rate of (42.4% vs 6.1%) and (37.5% vs 6.9%) in (DERMIS-1 & 2) trial, a significant improvement on 2EPs incl. on I-IGA Success, PASI-75, reductions in itch as measured by WI-NRS, and patient perceptions of symptoms. Efficacy results from the OLE study were maintained throughout treatment @6 & 12mos., was generally well-tolerated with a favorable safety and tolerability profile
  • Roflumilast’s NDA is also under US FDA’s review for the treatment of PsO in adolescents and adults with an expected US FDA decision on July 29, 202

Ref: Globenewswire | Image: Arcutis

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions